Enbrel Approved

 

May 28, 1999

                                                                                
The Associated Press
 By LAURAN NEERGAARD

WASHINGTON (AP) -- Some of the 50,000 American children who suffer debilitating rheumatoid arthritis won a potent new treatment Friday, the genetically engineered drug Enbrel.
Doctors welcomed the much-needed therapy but warned that it should be reserved for children with moderate to severe arthritis who have failed standard therapy. That's because Enbrel comes with a safety question:
Will it pose a serious risk of infection?
``It is somewhat concerning,´´ acknowledged Dr. William Schwieterman of the Food and Drug Administration, which approved Enbrel for children but ordered its maker to continue monitoring that question. But Schwieterman called Enbrel ``very good news´´ for children who have had few options. ``It´s very clear Enbrel is likely to provide a substantial number of them benefit,´´ he said.

Immunex Corp. began selling Enbrel for adult rheumatoid arthritis last winter. It attacks the disease in a way no other medicine does, soaking up an immune system protein called tumor necrosis factor that causes much of rheumatoid's inflammation before the substance can reach joints to damage them.

Doctors who treat juvenile rheumatoid arthritis immediately clamored to know if Enbrel would help arthritis' smallest sufferers, too.

The FDA approved Enbrel for children based on a study of 69 moderate to severe patients ages 4 to 17 who failed standard treatment. Enbrel helped 74 percent of them improve.

Katie Emmerson of West Covina, Calif., moved from a wheelchair to the school swimming team after joining the Enbrel study 1 1/2 years ago.  Initially, almost every joint was swollen and painful. She had failed all other therapies and was suffering severe side effects from
painkillers.

``She hadn´t been able to close her hand in two years, and she made a fist´´ 48 hours after her first Enbrel injection, mother Patti
Emmerson said. ``I´ll never forget. ... She said, ´Mom, I feel so
good.´´´

Today, Katie, 15, requires no other medication.

But the worry is that by inhibiting the immune system, Enbrel could
cause infections.

Two weeks ago, the FDA revealed that 30 of an estimated 25,000 adult Enbrel users have developed serious infections, and six have died. The FDA ordered Immunex to study whether the drug is to blame. Meanwhile, doctors were warned not to give Enbrel to any adults with active or chronic infections, and to be cautious in prescribing it to people with diseases like diabetes that increase infection risk. 


Sixty-two percent of children studied suffered some infection, but all
were mild cases, the FDA said. There's no way to tell if those were just routine childhood infections, but FDA said pediatricians should heed Enbrel's warnings and ordered Immunex to report how all child users fare.

``Kids do get infections multiple times during a year,´´ cautioned
Dr. Steven Abramson of the Hospital for Joint Diseases, an expert on
juvenile rheumatoid arthritis for the Arthritis Foundation.

But until doctors learn more about the potential risk, Abramson urged that only children with serious disease who aren't helped by other treatments try Enbrel.

``This is perhaps the most effective drug doctors have seen´´ in
years, so they may want to use it widely, Abramson said. ``I would still err on the side of being very conservative."

Back ] Up ] Next ]

DISCLAIMER:

The materials and information on this server are intended for educational and informational purposes only. The materials and information are not intended to replace the services of a trained health professional or to be a substitute for medical advice of physicians and/or other health care professionals. The International Still's Disease Foundation is not engaged in rendering medical or professional medical services. You should consult your physician on specific medical questions, particularly in matters requiring diagnosis or medical attention. The International Still's Disease Foundation makes no representations or warranties with respect to any treatment, action, application medication or preparation by any person following the information offered or provided within this website.  Any information used from other websites was done so with permission from each site, with an exception to those of "public domain", whereas we believe any site without a cited reference was a "public domain site" and for our use.  The International Still's Disease Foundation is a non-profit organization.   This page was last updated on January 17, 2001

Copyright© 1999-2001 International Still's Disease Foundation